Johnson & Johnson Vision, a member of Johnson and Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist located preferably in Colombia, or Mexico. An exciting opportunity to join a diverse team. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere. **Key Responsibilities**: - Conduct, and coordinate JJV regulatory activities for the countries in the Caribbean, Central America, Colombia and Venezuela and other countries in Latin America. - Implement strategies for new and existing products, based on business priorities, and global regulatory strategies to ensure timely commercialization of new or modified products in compliance with current and appropriate local regulations. - Support the supervision and positively influence the regulatory environment by representing the company in Regulatory industry associations and anticipating the impact of new and changing regulations on the company's portfolio of products. - To expedite approvals and to resolve post-submission queries and issues, communicate and conduct negotiations with Regulatory Agencies and/or commercial and regulatory partners, as needed. - Support the evaluation of proposed product modifications for Regulatory impact, completing Regulatory Assessments as needed. - Maintain the appropriate regulatory framework (processes, procedures, standards, etc.) to facilitate efficiency and compliance. - Support the preparation and management of the RA budget. - Ensure timely and accurate promotional materials review and approval and HA notification according to local advertising legal requirements. - Provide regulatory support to inspections/audits by producing requested documents or answering any inquiries for information. **Qualifications**: **Education**: - Bachelor’s Degree or Equivalent with focus on Regulatory Affairs. **Experience and Skills**: **Required**: - Minimum of 2 years of Regulatory experience in a highly regulated Medical Devices industry; - Good understanding of the regulatory regulation in Colombia, Central America and Caribbean; - Strong interpersonal and teammate skills; - Strong persuasive communication and influencing skills; - Strong problem-solving skills being able to accurately analyze situations and propose solutions; - Ability to prioritize multiple tasks and project. **Preferred**: - Regulatory knowledge of regulations in the Latin America region (Mexico, Peru, etc.); - Proactive, accurate, independent worker, has initiative; - Open-minded and business oriented. **Other**: - Typically, proficient in English and Spanish (both written and verbal); - May require up to 5% travel. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.